跳至主要内容
临床试验/NCT03221530
NCT03221530Unknown不适用

Early Intervention for Suicide Risk Among Immigrant Youth

Massachusetts General Hospital0 个研究点目标入组 40 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points

研究概览

简要总结

The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention will focus on reducing suicide risk by reducing family conflict and intergenerational cultural conflict and improving parent-child communication. The investigators will first develop the 8-session preventive intervention with quantitative data from analysis of existing longitudinal studies and qualitative feedback from Latino youth and their caregivers, clinicians, administrators, and research consultants, as well as results from initial pilot testing of the intervention. The investigators will then conduct a pilot randomized trial with 40 adolescents and their families to test feasibility, acceptability, and impact on intervention targets. Successful development of the intervention would improve mental health outcomes for a growing and underserved portion of the U.S. population.

详细描述

Suicide is the second-leading cause of death among adolescents, with rates increasing between 1999 and 2014. Family-based preventive interventions demonstrate promise for reducing suicide risk among adolescents, and are particularly relevant for addressing suicide risk factors specific to immigrant youth, who comprise one-fourth of the U.S. population under 18. The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. In the first phase of intervention development, quantitative and qualitative data will be used to develop and if necessary refine a new family based preventive intervention (Early Intervention for Suicide Risk among Immigrant Youth, EISR-I). The investigators will then test the intervention in a pilot case series in order to finalize assessment and intervention protocols. In the second phase, the investigators will pilot test the preventive intervention, delivered by mental health clinicians to 1st and 2nd generation Latino/a early adolescents and their families, in order to assess feasibility, acceptability, and impact on the intervention targets (i.e. a positive signal of the intervention) on the study population. Twenty families will be randomized to receive the 8-session intervention and twenty will receive enhanced usual care including a safety planning and feedback session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • First generation (foreign-born) or second-generation (at least one parent foreign-born) immigrant
  • 12 to 15 years old
  • Speaks English or Spanish
  • Reports current suicidal ideation with no plan, past-year suicidal ideation, or a suicide plan more than three months prior OR has a CAT-SS score>34

排除标准

  • Suicide attempt in the past three months
  • Endorses psychotic symptoms on a pre-study screener
  • Has severe major depressive disorder
  • Has a prior diagnosis of severe intellectual disability
  • Receiving individual or family therapy

结局指标

主要结局

Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points

时间窗: baseline, 3, 6, and 12 months

A self-report scale of suicidal ideation, plans and attempts

次要结局

  • Computerized Adaptive Test - Suicide Scale (CAT-SS); change from baseline at multiple time points(baseline, 3, 6, and 12 months)
  • Parent-Adolescent Communication Scale; change from baseline at multiple time points(baseline, 3, 6, and 12 months)
  • Family Relationship Index; change from baseline at multiple time points(baseline, 3, 6, and 12 months)
  • Family Cultural Conflict Scale; change from baseline at multiple time points(baseline, 3, 6, and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kiara Alvarez

Instructor

Massachusetts General Hospital

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